Adapted Cognitive Behavioral Treatment for Depression in Patients With Moderate to Severe Traumat… (NCT03307070) | Clinical Trial Compass
CompletedNot Applicable
Adapted Cognitive Behavioral Treatment for Depression in Patients With Moderate to Severe Traumatic Brain Injury
United States62 participantsStarted 2017-09-23
Plain-language summary
Cognitive behavioral therapy for major depressive disorder (MDD) was adapted for individuals with moderate to severe traumatic brain injury (TBI) (CBT-TBI). A structured, treatment manual was developed.
The primary aim is to evaluate the acceptability and tolerability of, and adherence to, CBT-TBI in a randomized waitlist-controlled, 12-week pilot trial (N=40).
The exploratory aim is to evaluate the potential efficacy of CBT-TBI for MDD in the randomized pilot trial (N=40) and possible moderators and mediators of outcome.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Adults aged 18 and older
✓. English language proficiency
✓. Ability to provide written, informed consent; OR consent provided by legally authorized representative with assent from subject
✓. Ability to see and hear (hearing or visual loss cannot impair ADLs or in-room conversation)
✓. Has access to a smartphone/tablet/computer with internet and video capabilities for virtual sessions
✓. Having been hospitalized for moderate to severe TBI that occurred at least 3 months prior to study entry
✓. Meeting ANY ONE of the following severity criteria, as documented in electronic medical record (EPIC) or available outside records:
✓. GCS 3-12 with GCS motor score ≤ 5 within 4 hours after injury
. Behavioral dyscontrol, defined as the presence of verbally or physically aggressive behavior in the past month, as evidenced in medical records, pre-screening interviews, or observed by any study staff
✕. Presents with PTSD as the primary diagnosis, as determined by a clinician
✕. Substance use disorder, moderate or severe, within the past 6 months
✕. Has bipolar disorder, a primary psychotic disorder or current psychotic symptoms, or acute suicidality or homicidality
✕. Currently receiving regular (≥ 2 times/ mo.) psychosocial treatment for depression
✕. Has participated in CBT for depression within the past 6 months
✕. Individuals with history of dementia or severe cognitive impairment that is not related to TBI (e.g., cognitive impairment requiring assistance with basic activities of daily living, such as getting ready in the morning)